21 CFR 864.9145
§ 864.9145 Processing system for frozen blood.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9145, § 864.9145 Processing system for frozen blood, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89410
- Permanent ID
ys:prov:89410@1- SHA-256
a71e4d4409469717b34bc3a5a46fe12b4fbc510552270a4f706c3eea9a6422fe
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Full text
(a) Identification. A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.